Recall Z-1536-2010 ยท FTL Mesh, Surgical, Polymeric
Davol, Inc., Sub. C. R. Bard, Inc.
Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI Product Code: 0010211 The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet, forming a positioning pocket. The Ventrio Hernia Patch is indicated for use in the reconstruction of sof
| Date | May 4, 2010 (initiated Apr 8, 2010) |
| Status | Terminated |
| Reason | Mislabeled: Product labeled as Small Oval (3.1" x 4.7") may contain Small Circle (3.0") |
| Root cause | Labeling mix-ups |
| Action | An "URGENT RECALL: BARD VENTRIO SMALL OVAL HERNIA PATCH (LOT DATB0015" letter dated April 8, 2010, was issued by the firm (Davol) to all customers via FedEx overnight with signature required. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to: please examine their inventory and immediately discontinue use of this lot; contact the Davol Customer Service Department at 1-800-556-6275 for instructions on how to return product to firm; complete and fax the EFFECTIVENESS CHECK sheet to 1-401-825-8753, and forward a copy of this letter |
| Quantity | 198 units |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081777 | VENTRIO HERNIA PATCH C.R. Bard, Inc., Sep 29, 2008 |